Customer Engagement & Background
A large acute NHS organisation operating across five sites and all clinical services was undertaking a major Electronic Patient Record (EPR) deployment programme. As part of its digital transformation strategy, the trust sought to ensure that existing and planned digital health systems met the requirements of DCB0160 Clinical Risk Management, were implemented safely, and had appropriate governance mechanisms in place to identify, assess and manage patient safety risks.
The trust engaged our Clinical Safety Officer Managed Service to provide dedicated clinical safety leadership and delivery capacity during a critical phase of the programme. The scope included retrospective and prospective clinical safety assessments for 33 digital systems used across the organisation, together with the development of DCB0129 and DCB0160 documentation for the trust’s own EPR solution.
The programme faced several significant challenges. Progress was dependent upon suppliers providing safety and compliance evidence, including DCB0129, DTAC, DSPT and medical device documentation, which was often unavailable or delayed. Historical safety documentation was dispersed across multiple teams and locations, making it difficult to establish a complete picture of existing controls and risks. The trust also needed to identify clinical subject matter experts, stakeholders and established risk management processes across five operational sites while maintaining momentum against demanding programme timelines.
Additional complexity arose from changing organisational priorities, with new digital services, including a trust wide virtual ward solution and medicines management platform, requiring DCB0160 compliance activity and assurance at short notice ahead of planned deployments.
Solution & Support Provided
We deployed a dedicated managed service comprising four full time Clinical Safety Officers and a dedicated Project Manager to provide comprehensive clinical risk management and assurance support throughout the programme.
Working collaboratively with clinical, operational and digital teams, we used the Assuric compliance platform to provide a centralised and transparent environment for clinical safety management. This enabled real time collaboration between Clinical Safety Officers, trust stakeholders, subject matter experts, digital teams, the CCIO, CNIO and project leadership while maintaining full auditability and visibility of progress.
Our team undertook a comprehensive programme of clinical safety activities across all identified systems, including:
DCB0160 Compliance and Clinical Safety Management
Led the development and maintenance of DCB0160 compliant clinical safety documentation for 33 digital systems, ensuring alignment with organisational governance requirements and national standards.
Clinical Hazard Identification and Risk Assessment
Facilitated hazard workshops, focus groups and stakeholder engagement sessions to identify potential patient safety risks associated with system implementation, integration and ongoing operational use.
Hazard Log Development and Maintenance
Produced and maintained detailed hazard logs, ensuring risks were appropriately assessed, controlled and tracked through to resolution or formal acceptance.
Safety Case and Clinical Safety Report Production
Developed Clinical Safety Cases, Clinical Safety Reports and associated assurance documentation to support deployment decisions and executive oversight.
Supplier Assurance and DCB0129 Reviews
Reviewed supplier supplied DCB0129 documentation and supporting safety evidence, identifying gaps and facilitating remediation where necessary.
Clinical Risk Assessment and Assurance Activities
Conducted system specific risk assessments, evaluated existing controls and introduced additional safeguards where required to reduce patient safety risks.
Go Live Readiness and Deployment Support
Provided rapid turnaround clinical safety support for time critical initiatives, including virtual ward and medicines management services, enabling compliance requirements to be met ahead of deployment deadlines.
Outcomes & Impact
The engagement delivered more than regulatory compliance. Through extensive hazard workshops, stakeholder engagement and user feedback activities, the programme identified a number of significant organisational digital safety issues that may otherwise have remained undiscovered.
Key findings included challenges relating to system integration, interoperability, data migration processes, parallel use of digital and paper workflows, and inconsistent digital training and staff induction arrangements across the organisation.
The programme resulted in the identification and assessment of:
- 12 unacceptable high severity hazards
- Approximately 38 significant undesirable hazards
- 455 safety recommendations and improvement actions
These findings enabled the trust to implement targeted controls, improve governance arrangements and strengthen organisational approaches to digital patient safety.
All programme milestones were delivered on schedule despite tight timescales and evolving requirements. The managed service successfully delivered more than two and a quarter years’ worth of accumulated DCB0160 backlog activity within a six month period, significantly accelerating the trust’s readiness for EPR deployment.
The work directly supported:
- Safe implementation of the trust’s EPR programme.
- Successful deployment of a trust wide virtual ward service.
- Successful deployment of a medicines management solution supporting pharmacy services.
- Improved visibility of digital risks across clinical and operational teams.
- Enhanced confidence among clinical, digital and executive stakeholders.
- Strengthened regulatory compliance and clinical risk management maturity.
- Reduced programme delays through rapid access to dedicated Clinical Safety Officer resource.
In addition to the patient safety and operational benefits realised, the trust achieved an estimated cost saving of approximately £35,000 when compared with using equivalent external consultancy Clinical Safety Officer resources over the same period.
By establishing a scalable, collaborative and highly responsive clinical safety model, the organisation was able to accelerate its digital transformation programme while ensuring patient safety remained central to every deployment decision.